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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K053518
Device Name INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
Applicant
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact KRISTINE LIBERACKI
Correspondent
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Correspondent Contact KRISTINE LIBERACKI
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/19/2005
Decision Date 01/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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